Biopsy devices and methods of use thereof

ABSTRACT

A biopsy device includes an ultrasonic probe, a display, an actuator, and a needle assembly. The display is associated with the ultrasonic probe, and the ultrasonic probe is configured to send a signal to the display to generate an image on the display. The needle assembly is coupled to the actuator and is at least partially disposed within a channel defined in the ultrasonic probe. The actuator is configured to move the needle assembly in a distal direction relative to the ultrasonic probe and through the channel of the ultrasonic probe from a retracted position to a deployed position.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional application of U.S. patent applicationSer. No. 15/490,963, filed on Apr. 19, 2017, which claims the benefit ofand priority to U.S. Provisional Patent Application No. 62/325,788,filed on Apr. 21, 2016, the entire contents of each of which areincorporated by reference herein, BACKGROUND

TECHNICAL FIELD

The present disclosure relates to biopsy sampling and, moreparticularly, to biopsy devices, biopsy systems, and methods fornavigating a biopsy device to a target location and obtaining a tissuesample using the biopsy device.

DESCRIPTION OF RELATED ART

To successfully treat cancer, it is critical to diagnose cancer at anearly stage. Various methods are used to identify the existence ofabnormalities in tissue prior to a patient being symptomatic. Forexample, women regularly go for prophylactic mammograms to determinewhether there are any early stage tumors developing in their breasttissue. Although mammography is effective at identifying whether a tumoris present, mammography is not capable of differentiating between benignand malignant tumors. Accordingly, upon identifying an abnormality inthe tissue, the status of the abnormality needs to be determined usingadditional diagnostic technique.

One method to verify whether a tissue is cancerous is to obtain a tissuesample for histological examination through a biopsy of the tissue(e.g., breast tissue) near the lesion. There are a number of devices andmethods for performing a biopsy. In some instances, a tumor may beidentified using manual palpation of the breast tissue and then a biopsyneedle may be positioned over the identified tumor to take a sample oftissue. Another method involves holding an ultrasound probe in one handwhile holding the biopsy needle h a second hand and guiding the biopsyneedle along the image plane of the ultrasound probe.

Proper placement of the biopsy needle in the target tissue is importantfor accurate breast cancer diagnosis. As already noted, traditionalbreast biopsy techniques involve blind, manual palpation of the lesionor the use of a separate imaging guidance system. Small lumps ofcancerous tissue may be mobile, and therefore may be pushed away by thebiopsy device during insertion of the biopsy device into the targettissue. Some tissue may be hard, and therefore may deflect the biopsydevice during insertion into the target tissue, resulting in theclinician removing tissue samples from only a small portion of the sideof the target tissue.

SUMMARY

Provided in accordance with the present disclosure is a biopsy deviceincluding an ultrasonic probe, a display, an actuator, and a needleassembly. The display is associated with the ultrasonic probe, and theultrasonic probe is configured to send a signal to the display togenerate an image on the display. The needle assembly is coupled to theactuator and is at least partially disposed within a channel defined inthe ultrasonic probe. The actuator is configured to move the needleassembly in a distal direction relative to the ultrasonic probe andthrough the channel of the ultrasonic probe from a retracted position toa deployed position.

In some embodiments, the ultrasonic probe may be configured to captureimages of the target lesion and the needle position at the extent oftravel or at the instance the sample is captured within the needle. Thebiopsy device may include a processor for storing the image andtransferring a memory and the needle assembly, or otherwise transmittingthe image with reference, to the needle assembly specific ID.

The biopsy device is contemplated to have a sterile cover to prevent theultrasonic probe from contacting the skin of the patient. The sterilecover may have a window for the ultrasonic sensor. The window may becomposed of a silicone, plastic and/or gel material and may beultrasonically conductive. The silicone or ultrasonically conductivematerial may have sufficient thickness to include a majority of a depthof a shadow formed by the gap or hole in the sensor through which theneedle passes.

In embodiments, the needle assembly may be a selectively attachablecartridge that may be composed of a coring needle or a needle assemblywith a notched core and a sliding sleeve. The needle may be safelypositioned inside the cartridge preventing unintended contact that couldresult in a puncture to the user or loss of sterilization of the needlesurface. The cartridge may have a unique ID that is traceable to thepathologic outcomes by transmitting the ID by electronic means to thehandle processor or a connected patient record system.

In some methods, a verification image of the biopsy may be captured asproof that the needle successfully captured the tissue. The cartridge isextracted with the captured portion of tissue to a location forpathologic analysis along with the captured ultrasonic imagingconfirming the biopsy location.

In most aspects of the present disclosure, the disclosed biopsy devicesare designed to enable the user to target and execute a biopsy with asingle hand. The second hand is free for manipulating the breast tissueto control the target location, and bunch or flatten the tissue asneeded to achieve appropriate needle depth rather than adjusting theneedle depth within the device.

In some embodiments, the ultrasonic probe may define a longitudinal axistherealong. The ultrasonic probe emits ultrasonic waves such that themovement of the needle assembly from the retracted position toward thedeployed position aligns with the ultrasonic waves. The ultrasonic probemay be configured to send signals to the display corresponding to aposition of a needle of the needle assembly to generate an image on thedisplay of the position of the needle of the needle assembly.

It is contemplated that the needle assembly may include a hub and aneedle extending distally from the hub. The actuator may be configuredto rotate the needle about a longitudinal axis thereof after the needleassembly is moved from the retracted position to the deployed position.

It is envisioned that the needle assembly may include a body thatdefines a chamber therein, and a needle extending distally from thebody. The biopsy device may further include a tube extending alongsidethe needle.

In some embodiments, the biopsy device may further include an adjustmentmechanism movably coupled to the ultrasonic probe and configured toadjust and set a needle depth of the needle assembly such that anactuation of the actuator moves the needle assembly from the retractedposition to the deployed position a longitudinal distance correspondingto the needle depth set by the adjustment mechanism.

It is contemplated that the ultrasonic probe may include a distal capdefining a central opening having a needle of the needle assemblyextending therethrough. The distal cap may have a window for conductingultrasound waves therethrough.

It is envisioned that the biopsy device may include a force sensorcoupled to a distal end portion of the ultrasonic probe and extendingdistally beyond a distal end portion of the needle assembly whendisposed in the retracted position. The ultrasonic probe may include anannular member extending distally from the distal end portion thereof.The force sensor may include a plurality of force sensors disposed in anannular array on the annular member.

In another aspect of the present disclosure, a method of performing abiopsy is provided. The method includes positioning a biopsy device inproximity to target tissue; generating an image of the target tissue ona display of the biopsy device using an ultrasonic probe of the biopsydevice; aligning a needle of a needle assembly that is disposed withinthe ultrasonic probe with the target tissue using the image of thetarget tissue generated on the display; and deploying the needle of theneedle assembly from the ultrasound probe into the target tissue,thereby capturing a tissue sample from the target tissue in the needle.

In some methods, aligning the needle with the target tissue may includemoving the biopsy device relative to the target tissue into a positionin which a projected needle pathway animated on the display is in linewith the image of the target tissue on the display. Deploying the needleinto the target tissue may include guiding the needle into the targettissue along the projected needle pathway.

The method may further include automatically capturing an image of theneedle of the needle assembly with the tissue sample disposed therein.

The method may further include abutting a force sensor of the biopsydevice with a tissue surface to determine a resistance of the targettissue prior to deploying the needle into the target tissue.

In some methods, a negative pressure may be applied to the needleassembly to draw the tissue sample into a containment chamber of theneedle assembly. The negative pressure may be applied using hydraulicsor a vacuum.

As used herein, the term “distal” refers to the portion that is beingdescribed which is further from a user, while the term “proximal” refersto the portion that is being described which is closer to a user.Further, to the extent consistent, any of the aspects and featuresdetailed herein may be used in conjunction with any or all of the otheraspects and features detailed herein.

As used herein, the terms parallel and perpendicular are understood toinclude relative configurations that are substantially parallel andsubstantially perpendicular up to about + or −10 degrees from trueparallel and true perpendicular.

BRIEF DESCRIPTION OF THE DRAWINGS

Various aspects and features of the present disclosure are describedhereinbelow with references to the drawings, wherein:

FIG. 1 is a perspective view of an ultrasonic biopsy device provided inaccordance with the present disclosure configured for navigation to atarget location and for obtaining a tissue sample;

FIG. 2A is a perspective view of the ultrasonic biopsy device of FIG. 1and a cover;

FIG. 2B is a perspective view of the ultrasonic biopsy device of FIG. 1illustrating the cover of FIG. 2 attached thereto;

FIG. 3 is a partial perspective view of a needle depth stop attached toa needle assembly of the biopsy device of FIG. 1;

FIG. 4 is a front view of the ultrasonic biopsy device of FIG. 1 duringinsertion and navigation to a target tissue;

FIG. 5A is a side view of a needle of the biopsy device of FIG. 1;

FIG. 5B is a side view of the needle of FIG. 5A having a sample oftissue disposed therein;

FIGS. 6A-6E illustrate various methods of using the needle of FIG. 5A toextract a tissue sample;

FIGS. 7A-7D illustrate a method of extracting two tissue samples usingthe ultrasonic biopsy device of FIG. 1;

FIG. 8A is a partial perspective view of another embodiment of a needleassembly, for use with the ultrasonic biopsy device of FIG. 1;

FIG. 8B is a partial perspective view of the needle assembly of FIG. 8Aafter rotation thereof;

FIG. 9 is a partial perspective view of another embodiment of a needlefor use with the ultrasonic biopsy device of FIG. 1;

FIG. 10A perspective view, with parts separated, of another embodimentof a needle assembly for use with the ultrasonic biopsy device of FIG.1;

FIG. 10B is a perspective view of the needle assembly of FIG. 10A in anassembled state;

FIG. 11 is a partial perspective view of another embodiment of a needlefor use with the ultrasonic biopsy device of FIG. 1;

FIGS. 12A-12E illustrate a method of extracting a tissue sample usingyet another embodiment of a needle assembly;

FIG. 13A is a perspective view of another embodiment of a biopsy devicein accordance with the present disclosure;

FIG. 13B is a bottom view of the biopsy device of FIG. 13A;

FIG. 14 is a front view of yet another embodiment of a biopsy device inaccordance with the present disclosure;

FIG. 15A is a perspective view of still yet another embodiment of abiopsy device in accordance with the present disclosure including aplurality of force sensors;

FIG. 15B is an enlarged perspective view of one of the force sensors ofthe biopsy device of FIG. 15A;

FIG. 16 is a schematic view of the ultrasonic biopsy device illustratinga pathway for a needle;

FIG. 17 is a schematic view of the ultrasonic biopsy device illustrating8 and 9 channel ultrasound modules;

FIG. 18 is a schematic view of the ultrasonic biopsy device illustratingone ultrasound module;

FIG. 19 illustrates a scan sequence;

FIGS. 20A-20C illustrate a method of using another embodiment of abiopsy device;

FIG. 21 is a front, cross-sectional view of a fluid station for use withany of the biopsy devices of the present disclosure;

FIG. 22 is a perspective view of yet another embodiment of an ultrasonicbiopsy device in accordance with the principles of the presentdisclosure;

FIG. 23 is a cross-sectional view, taken alone line 23-23, of theultrasonic biopsy device of FIG. 22;

FIG. 24 illustrates the ultrasonic biopsy device of FIG. 23 in adisassembled state;

FIG. 25 illustrates the ultrasonic biopsy device of FIG. 23 in apartially disassembled state;

FIG. 26 is a front view, with parts removed, of the ultrasonic biopsydevice of FIG. 22;

FIG. 27 is a perspective view, with some parts removed, of theultrasonic biopsy device of FIG. 22;

FIG. 28 illustrates the ultrasonic biopsy device of FIG. 23 in a firstpre-firing state;

FIG. 29 illustrates the ultrasonic biopsy device of FIG. 23 in a secondpre-firing state;

FIG. 30 illustrates the ultrasonic biopsy device of FIG. 23 in a firedstate; and

FIG. 31 illustrates the ultrasonic biopsy device of FIG. 23 in apost-fired state.

DETAILED DESCRIPTION

Biopsy devices, biopsy systems, and methods for navigating the biopsydevices to a target location and obtaining a tissue sample using thebiopsy device are provided in accordance with the present disclosure anddescribed in detailed below. In one embodiment, the biopsy deviceincludes a handle assembly in the form of an ultrasonic probe, and aneedle coupled to the handle assembly and configured for penetrating andextracting tissue from a lesion. The handle assembly has a display orscreen for illustrating both a needle tip of the needle and the targettissue such that the needle can be accurately navigated into thetargeted portion of the lesion.

Detailed embodiments of such biopsy devices, systems incorporating suchbiopsy, devices, and methods using the same are described below.However, these detailed embodiments are merely examples of thedisclosure, which may be embodied in various forms. Therefore, specificstructural and functional details disclosed herein are not to beinterpreted as limiting, but merely as a basis for the claims and as arepresentative basis for allowing one skilled in the art to variouslyemploy the present disclosure in virtually any appropriately detailedstructure.

With reference to FIGS. 1, 2A, and 2B, a biopsy device 100 is providedin accordance with the present disclosure for obtaining a tissue samplefrom a target tissue, for example, a lesion. The biopsy device 100generally includes a handle assembly 102 and a needle 120 disposedwithin the handle assembly 102. The handle assembly 102 includes ahandle body 104 in the form of a hand-held ultrasonic probe 104, and adisplay 106. The hand-held ultrasonic probe 104 is configured to performultrasonic imaging at a distal portion 104 b thereof. Ultrasonic probe104 has a proximal portion 104 a on which the display or screen 106 isdisposed. The ultrasonic probe 104 communicates with the display via acentral processing unit (not shown) disposed within the probe 104 todisplay an image corresponding to the signals received from the probe104.

The handle assembly 102 may house a memory (e.g., an EEPROM—not shown)for storing a variety of information regarding the biopsy device 100. Inaddition, the memory may store operating parameters of the biopsy device100, e.g., power, time, RPM limits, and information regarding the usageof the biopsy device 100. Usage monitoring may enable limiting there-use of the biopsy device 100 beyond a certain number of activations,amount of activation time, or may limit the biopsy device 100 to asingle use. Such usage limitations may optionally be reset viareprocessing as is commonly understood in the art.

With continued reference to FIG. 1, the handle assembly 102 may includean adjustment mechanism 108 movably coupled to the probe 104 b. Inembodiments, the adjustment mechanism 108 may be configured as a slider.The adjustment mechanism 108 is in communication with the centralprocessing unit or microprocessor (not shown) of the biopsy device 100and is configured to adjust and set a needle depth of the needle 120, aswill be described in detail below. The handle assembly 102 may includean actuator or needle firing button 110 coupled to the probe 104 andconfigured to fire the needle 120 into target tissue.

The needle 120 of biopsy device 100 has a proximal end portion 120 a anda distal end portion 120 b configured to penetrate tissue. The proximalend portion 120 a of the needle 120 is operably coupled to the actuator110 of the handle assembly 102 such that actuation of the actuator 110distally moves the needle 120 relative to the distal end portion 104 bof the probe 104 along a longitudinal axis defined by the needle 120.The needle 120 may be moved distally relative to the handle assembly 102via a spring (not shown) that is preloaded and released upon actuationof the actuator 110. In some embodiments, any suitable mechanism forfiring the needle 120 may be implemented, for example, anelectromechanical drive, pressurized pneumatics, a manual drive screw,or the like. Alternately, the biopsy device 100 may be configured toconnect to a remote drive and/or power source (not shown) to driveactuation of the needle 120.

The distal end portion 120 b of the needle 120 is hollow such thatinsertion of the needle 120 into tissue captures tissue in a hollowinterior defined in the needle 120. In some embodiments, the needle 120may be configured as a cannula having a sharpened distal end. The distalend portion 120 b of the needle 120 is disposed within the handleassembly 102 when the needle 120 is in the un-actuated condition, andextends distally from the handle assembly 102 when in the deployed oractuated condition. As the needle 120 moves from the un-actuatedcondition to the deployed condition, the needle 120 passes through anultrasound sensor or transducer (not explicitly shown) of the probe 104in alignment with the direction of the ultrasonic waves.

The probe 104 is configured to send ultrasonic waves toward the distalend portion 120 b of the needle 120, whereby the distal end portion 120b reflects sound waves back to the probe 104, Which, in turn, sends thereflected sound waves to the central processing unit of the biopsydevice 100. The central processing unit generates an image of the distalend portion 120 b of the needle 120 on the display 106.

With reference to FIGS. 2A and 2B, sterility of the ultrasonic probe 104may be maintained by use of a custom cap or sterile cover 130 that isremovably coupled to the distal end portion 104 b of the probe 104. Thesterile cover 130 serves as a barrier between the ultrasonic probe 104and a patient's skin. Ultrasound gel may be dispensed inside the cover130 or may be pre-packaged with a layer of gel and a rip tab. The cover130 defines a central opening 132 that has the needle 120 extendingtherethrough when the cover 130 is attached to the distal end portion104 b of the probe 104. The cover 130 permits ultrasound propagationtherethrough while preventing the probe 104 from directly contacting apatient. The cover 130 may include a window 134 formed ofultrasound-opaque material.

The adjustment mechanism 108 and the actuator 110 are in communicationwith the central processing unit (not shown) of the handle assembly 102.As mentioned above, the adjustment mechanism 108 sets the depth thatneedle 120 can penetrate target tissue. Specifically, the adjustmentmechanism 108 sets the amount that the needle 120 moves distallyrelative to the handle assembly 102 upon actuating the needle firingbutton 110. As such, upon actuation of the needle firing button 110, theneedle 120 moves distally relative to the handle assembly 102 a selectedlongitudinal distance corresponding to the needle depth set by theadjustment mechanism 108.

In one embodiment, as shown in FIG. 3, the biopsy device 100 may includea needle depth stop 140 extending distally from the ultrasonic probe104. The depth stop 140 may be configured as a tube that surrounds theneedle 120 of the biopsy device 100 and extends distally beyond theneedle tip 120 b of the needle 120 when the needle 120 is in theretracted position. The distance the depth stop 140 extends distallyrelative to the needle tip 120 b may be manually adjusted. In this way,to set the penetration depth of the needle 120, the depth stop 140 ismoved axially relative to the distal end portion 104 b of the ultrasonicprobe 104.

One use of the biopsy device 100 for extracting tissue samples from alesion, e.g., a tumor, is described in detail with reference to FIGS. 1and 4. The biopsy device 100 is positioned such that the distal endportion 104 b of the probe 104 is placed in abutting engagement with anouter surface “S” of tissue (e.g., breast tissue), with the distal endportion 120 b of the needle 120 in proximity to target tissue, e.g., alesion “L.” The probe 104 is activated to emit an ultrasonic field “UF”toward the lesion “L.” and the distal end portion 120 b of the needle120. The probe 104 then receives the reflected sound waves and thecentral processing unit (not shown) of the probe 104 generates an imageof the distal end portion 120 b′ of the needle 120 relative to thelesion “L′” on the display 106. In addition, the central processing unitof the biopsy device 100 may animate a projected needle pathway “P′” onthe display 106 such that a clinician can accurately predict the pathway“P” the needle 120 will travel at any given moment if actuated. Thebiopsy device 100 is moved to a position in which the projected needlepathway “P′” animated on the display 106 is aligned with the image ofthe lesion “L.′” At this time, or at any suitable time, the adjustmentmechanism 108 (FIG. 1) may be moved to set the needle depth of theneedle 120. Alternatively, if the depth stop 140 (FIG. 3) is provided,the depth stop 140 may be moved to set the needle depth of the needle120. The cross-hairs 106 a and 106 b on the display 106 provide guidancerelating to the depth of the needle 120 when deployed.

Upon aligning, on the display 106, the projected needle pathway “P′”with the displayed image of the lesion “L,′” on the display 106, theneedle actuator 110 may be actuated to move the needle 120 along theprojected needle pathway “P” in situ a longitudinal distancecorresponding to the needle depth set by the adjustment mechanism 108.In some embodiments, the biopsy device 100 may be moved manually in thedistal direction to penetrate the lesion “L” with the needle 120. As theneedle 120 penetrates the lesion “L,” a first tissue sample of thelesion “L” enters the distal end portion 120 b of the needle 120. Insome embodiments, the needle 120 is a center coring needle. In otherembodiments, as shown in FIG. 11, the needle 120 may be a side-bitingneedle.

With reference to FIGS. 5A and 5B, in some embodiments, prior to drivingthe distal end portion 120 b of the needle 120 into the lesion “L,” astylet 122 may be driven through the needle 120 and into the lesion “L”to act as an introducer and to control the starting point of the tissuesample. After inserting the stylet 122, the stylet 122 may be retractedback into the needle 120, and the needle 120 may then be driven distallyinto the lesion “L.” Alternately, instead of manually retracting thestylet 122 back into the needle 120, distal penetration of the needle120 into the lesion “L” may drive the stylet 122 back into the needle120 allowing the first tissue sample “TS1” to enter the distal endportion 120 b of the needle 120.

With reference to FIGS. 6A-6D, various methods may be employed to moreeffectively extract the first tissue sample “TS1” from the lesion “L”and into the needle 120. For example, with reference to FIG. 6A, theneedle 120 may be vibrated inside of the lesion “L.” The needle 120 maybe vibrated using the ultrasound probe 104, a vibration motor,transducer, or any suitable mechanism capable of causing the needle 120to vibrate. With reference to FIG. 6B, the needle 120 may be swung orpivoted about an axis that extends perpendicularly through the needle120. With reference to FIG. 6C, the needle 120 may be configured as anelectrosurgical needle capable of emitting high frequency radiation toassist in extraction of the first tissue sample “TS1.” With reference toFIG. 6D, the distal end portion 120 b of the needle 120 may be firstinserted into the lesion “L,” extracted from the lesion “L,” pivotedrelative to the lesion “L” to a different angle, and then re-insertedinto the lesion “L” at the different angle. With reference to FIG. 6E,the needle 120 may be rotated about its longitudinal axis to assist intissue extraction.

In some embodiments, after capturing the tissue sample “TS1” in theneedle 120, a vacuum may be established proximally of the needle 120 bya one-way valve (not shown) or by drawing a negative vacuum with asyringe or pump. The tissue sample “TS1” may be collected within theneedle 120 or in a tissue chamber (not shown) of the needle 120. Suctionmay be applied in a controlled manner so as to maintain the tissuesample “TS1” intact. In some embodiments, a vacuum or suction source maybe used to trap the tissue sample “TS1.” within the needle 120. In someembodiments, the biopsy system 100 may include a tissue containmentchamber that collects tissue samples for testing. In one embodiment, apressurized fluid may be used to drive the tissue sample “TS1” from theneedle into the tissue chamber.

With reference to FIGS. 7A-7D, after inserting the distal end portion120 b of the needle 120 into the lesion “L,” the distal end portion 120b of the needle 120 may be withdrawn from the lesion “L” carrying thefirst tissue sample “TS1” therein. Proximal withdrawal of the distalportion 120 b of the needle 120 from the lesion “L” is continued until adistal-most point 123 of the needle 120 reaches an entry hole 124defined in the outer surface of the lesion “L.” While maintaining thedistal-most point 123 of the needle 120 at the entry hole 124, theneedle 120 is then angled relative to the lesion “L” such that theneedle 120 assumes a second projected needle pathway “P2,” angledrelative to the first needle pathway “P1.” The needle 120 is thenre-inserted into the access hole 124 along the second pathway “P2,”thereby capturing a second tissue sample “TS2” of the lesion “L” in theneedle 120. In some embodiments, rather than re-inserting needle 120into access hole 124 a second time, the needle 120 may be insertedthrough a different hole (not shown) of lesion “L” to capture the secondtissue sample “TS2.” The needle 120 is then retracted into the probe 104and out of the tissue.

The tissue samples “TS1,” “TS2” may be discharged out of the distal-mostend 124 of the needle 120, or be removed from a syringe-portion of theneedle 120. In some embodiments, the tissue samples “TS1,” “TS2” may beexpelled from the needle 120 using a tissue sample removal system (notshown) coupled to the biopsy device 100 which discharges a fluid (e.g.,air or liquid) distally through needle 120. In some embodiments, thetissue sample removal system may be integrally formed with the biopsydevice 100.

In embodiments, the biopsy device 100 may include a mechanism configuredto deploy a marker or tracking device into the lesion “L.” For example,the needle 120 may include a spring configured to deploy the marker fromthe distal-most end 124 of the needle 120 or a side opening in theneedle 120. After deployment of the marker, the needle 120 may beautomatically retracted into the biopsy device 100. In embodiments, uponthe needle 120 terminating its deployment, the biopsy device mayautomatically capture an image of the tissue sample disposed in theneedle 120 or at the instant the needle 120 penetrates the tissuesample.

In one embodiment, as shown in FIGS. 8A and 8B, the needle 120 of thebiopsy device 100 may be replaced with a side-biting needle 150, whichincludes an outer cannula 150 a and a notched inner cannula or rod 150 bdisposed within the outer cannula 150 a. The side-biting needle 150 mayinclude a wire 152 having a first end 152 a attached to a distal endportion of the outer cannula 150 a and a second end 152 b attached to adistal end portion of the inner cannula 150 b. When the side-bitingneedle 150 is actuated, the notched inner cannula 150 b is deployed intothe lesion “L” followed by a rotating of the cannulas 150 a, 150 brelative to one another to sever the tissue with the wire 152. Only oneof the cannulas 150 a, 150 b may be configured to rotate with respect tothe other of the cannulas 150 a, 150 b. After deployment, the inner andouter cannulas 150 a, 150 b are retracted into the handle assembly 102.

In another embodiment, as shown in FIG. 9, the needle 120 of the biopsydevice 100 may be replaced with another embodiment of a needle 160 thatincludes a metal wire 162 that extends across a tip 164 of the needle160. In embodiments, the wire 162 may be any suitable material capableof severing tissue. In use, after the needle 160 captures a tissuespecimen therein, the needle 160 is rotated about its longitudinal axis.During rotation of the needle 160, the wire 162 severs the tissuespecimen at its base allowing for its removal from the tissue site.

In yet another embodiment, as shown in FIGS. 10A and 10B, the needle 120of the biopsy device 100 may be replaced with a needle assembly 170,which includes a hub or body 172 and a needle 174 extending distallytherefrom. The needle assembly 170 may further include a hub cover 176configured to fit over the hub 172 of the needle assembly 170, and awire 178 having opposing ends 178 a, 178 b attached to opposing sides ofthe hub cover 176. Upon positioning the hub cover 176 over the hub 172,the wire 178 extends taught across a needle tip 175 of the needle 174.In use, after the needle 174 captures a tissue specimen therein, theneedle assembly 170 is rotated about its longitudinal axis. Duringrotation of the needle assembly 170, the wire 178 severs the tissuespecimen at its base allowing for its removal from the tissue site.

In some embodiments, the needle of the biopsy device 120 may include abarb or hook that extends into the internal passageway of the needle.The barb may be configured to allow for the passage of tissue into theinternal passageway, but inhibit the tissue from moving distally out ofthe needle.

With reference to FIG. 11, another embodiment of a needle 180 to be usedwith the biopsy device 100 is illustrated. The needle 180 includes apair of flaps 182 a, 182 b formed with a distal end portion of theneedle 180. The flaps 182 a, 182 b are configured to move from a firststate in which the flaps 182 a, 182 b extend in line with an outersurface of the needle 180, and a second state (as shown in FIG. 11) inwhich the flaps 182 a, 182 b extend into an internal passageway 184 ofthe needle 180. The tabs 182 a, 182 b may be fabricated from a shapememory alloy, e.g., nitinol, configured to move from the first state tothe second state upon receiving an electrical impulse or upon changingto a particular temperature body temperature). In use, the needle 180 isdeployed into tissue with the tabs 182 a, 182 b in their first state.After the needle 180 captures a tissue specimen therein, the tabs 182 a,182 b are shifted toward their second state (e.g., via receiving anelectrical impulse), and ends of the tabs 182 a, 182 b cut into thetissue specimen at its base allowing for its removal from the tissuesite.

With reference to FIGS. 12A-12E, another embodiment of a needle assembly190 for use with the biopsy device 100 is illustrated. The needleassembly 190 includes a hollow hub or body 192 and a needle 194extending distally therefrom and in fluid communication therewith. Theneedle assembly 190 further includes a tube 196 attached to or formedwith an outer surface of the needle 194. The tube 196 extends parallelwith and alongside the length of the needle 194. The tube 196 defines achannel 198 therethrough which acts as a ventilation channel to mitigatea tissue suction effect that may occur during removal of a tissuespecimen from tissue “T.”

In use, upon inserting the needle 194 of the needle assembly 190 intotissue “T,” the tube 196 has a rod (not shown) disposed in the channel198 of the tube 196 to prevent tissue from entering the channel 198 ofthe tube 196. The needle assembly 190 is rotated about its longitudinalaxis to sever a tissue specimen captured in the needle 194. As theneedle assembly 190 is rotated, the tube 196 radially expands the hole“H” formed by the needle 194 upon entering the tissue “T” to form aspace “S” between the needle 194 and the tissue “T.” As the needleassembly 194 is extracted from the tissue “T,” the rod is removed fromthe channel 198 of the tube 196 to allow air to travel through thechannel 198 and into the hole “H” formed in the tissue “T.” This has theeffect of preventing a vacuum from being formed in the hole “H” of thetissue “T” during removal of the needle 194, which would otherwise causethe tissue specimen to be drawn distally out of the needle 194 duringextraction.

With reference to FIGS. 13A and 13B, another embodiment of a biopsydevice 200 is provided. The biopsy device 200 is substantially similarto the biopsy device 100 described above. Accordingly, the biopsy device200 will only be described in sufficient detail to elucidate selecteddifferences from biopsy device 100. The biopsy device 200 includes ahandle assembly 202, and a needle assembly or cartridge 220 configuredto be removably coupled to the handle assembly 202, The handle assembly202 may be an ultrasonic probe having a display 206 for displaying anultrasonic image. The handle assembly 202 includes a sheath orprotective sleeve 212 configured to cover a distal portion of the handleassembly 202. The sleeve 212 permits ultrasound propagation therethroughwhile preventing the handle assembly 202 from directly contacting apatient. The sleeve 212 may include a window formed of ultrasound-opaquematerial. In some embodiments, the sleeve 212 may have pre-appliedultrasound gel disposed on a portion or portions thereof.

The handle assembly 202 has a longitudinally-extending channel 214defined in the distal portion thereof. Needle assembly 220 includes amedical syringe 220 a fitted with a needle 220 b. The channel 214 isconfigured to receive the needle assembly 220 therein. In someembodiments, the protective sleeve 212 and/or the channel 214 may beincorporated into the biopsy device 100 of FIG. 1. The needle assembly220 may be actuated or deployed in a similar manner as described herein(e.g., via biasing members) or in any other suitable way known in theart. During actuation, the needle assembly 220 is moved relative to thehandle assembly 202 distally along a longitudinal axis defined by thebiopsy device 200.

With reference to FIG. 14, another embodiment of a biopsy device 300 isillustrated. The biopsy device 300 is substantially similar to thebiopsy device 100 described above. Accordingly, the biopsy device 300will only be described in sufficient detail to elucidate selecteddifferences from biopsy device 100. The biopsy device 300 includes anactuation spring 302 and a motor 304 for driving actuation of a needle320 of the biopsy device 300. The motor 304 raises a platform 306 onwhich the needle assembly 320 is supported to compress or load theactuation spring 302. Upon setting the motor 304 in neutral, the load ofthe actuation spring 302 drives the needle assembly 320 in a distaldirection.

With reference to FIGS. 15A and 15B, another embodiment of a biopsydevice 400 is illustrated. The biopsy device 400 is substantiallysimilar to the biopsy device 100 described above. Accordingly, thebiopsy device 400 will only be described in sufficient detail toelucidate selected differences from biopsy device 100. The biopsy device400 includes a handle body 402, a needle assembly 420 connected to thehandle assembly 402, and a collar or annular member 430 extendingdistally from the handle body 402. The collar 430 encapsulates theneedle assembly 420 and extends distally beyond a distal-most end of theneedle assembly 420 when the needle assembly 420 is in an unactuatedposition.

The biopsy device 400 includes a plurality of force sensors 440 disposedin an annular array on a distally-oriented surface 432 of the collar430. In some embodiments, the force sensors 440 and/or the collar 430may be incorporated into the biopsy device 100. Each sensor 440 has asensor plate 442 fixedly coupled to the distally-oriented surface 432 ofthe collar 430, a proximal body 444 fixed to the sensor plate 442, and adistal body 446 that is slidably coupled to the proximal body 444. Eachsensor 440 has a biasing member, such as, for example, a coil spring448, disposed between the proximal and distal bodies 444, 446 of each ofthe sensors 440, to resiliently bias the distal body 446 away from theproximal body 444.

The force sensors 440 are in communication with a central processingunit or processor (not shown) of the handle assembly 402. The forcesensors 440 relay the forces sensed by each force sensor 440 to theprocessor, which sends the signals to a user interface, for example, adisplay (not shown). In this way, the force sensors 440 may allow forthe determination of an amount of resistance of the tissue against theneedle assembly 420, which can be used to confirm that a targeted lesionhas been correctly targeted, and that the needle assembly 420 has passedthrough the lesion and has not struck critical structures such as achest wall.

With reference to FIGS. 16-19, two 64-element transducer arrays areoriented to allow a needle pathway between them. The signal may beprocessed in one of at least two ways. With reference to FIG. 16, oneway to process the signal is two 8-channel handheld ultrasound modulesthat generate ultrasound pulses and sample reflected signals. Eachmodule performs synthetic aperture beamforming independently and thebeamformed data is then merged in a processor into B-mode images. Thescan sequence of this mode is illustrated in FIG. 16. The processor thensends the merged data on a USB connection to a computer with softwarethat reads the beamformed data from the USB and displays a B-mode imageon the screen.

With reference to FIG. 17, another way of processing the signal is asingle 16-channel handheld ultrasound module used with syntheticaperture beamforming. The transmitter fires spherical waves individuallyor with every two elements, instead of firing focused beams with a widertransducer aperture. One advantage of employing the synthetic aperturemethod is it offers flexibility in configuring the transducers. In thiscase, by using a single beamformer, it enables placing two or moreseparate transducer arrays at different positions and possibly differentorientations without creating a mismatch at the border of two halfimages. The scan sequence is shown in FIG. 18. The ultrasound image isconstructed either after each cycle of the aperture coverage, or aftereach firing.

With reference to FIGS. 20A-20C, another embodiment of a biopsy device500 is illustrated. The biopsy device 500 includes a handle assembly 510and a needle assembly or cartridge 520 extending distally from thehandle assembly 510. The handle assembly 510 incorporates an ultrasonictransducer (not explicitly shown) such that the handle assembly 510 actsas an ultrasonic probe. In embodiments, the handle assembly 510 of thebiopsy device 500 may be devoid of an ultrasonic transducer.

The needle assembly 520 includes a body or hub 522 and a needle 524extending distally from the body 522. The body 522 of the needleassembly 520 has a proximal end 522 a disposed within an internalchamber 512 defined in the handle assembly 510, and a distal end 522 bdisposed distally of the handle assembly 510. The proximal end 522 a ofthe body 522 defines an opening 526 in fluid communication with theinternal chamber 512 of the handle assembly 510. The body 522 of theneedle assembly 520 includes a flange 528 extending radially outward ofthe proximal end 522 a thereof. A biasing member 530 (e.g., a swing) isdisposed between the flange 528 of the body 522 and an internalstructure of the handle assembly 510 to resiliently bias the needleassembly 520 in a distal direction. As such, upon an actuation of anactuator 514 of the handle assembly 510, the needle assembly 520 isreleased, thereby allowing the biasing member 530 to move the needleassembly 520 in a distal direction from a retracted position to adeployed position.

The biopsy device 500 also includes a syringe 540 axially aligned withthe needle assembly 520 and disposed within the handle assembly 510. Atube 542 of the syringe 540 has a distal end 544 defining an opening 546dimensioned for receipt of the proximal end 522 a of the body 522 of theneedle assembly 520. The syringe tube 542 of the biopsy device 500contains a fluid (e.g., water) therein. In embodiments, the syringe tube542 may include a gas. A plunger 548 of the syringe 540 is movablydisposed within the syringe tube 542. Upon coupling the distal end 544of the syringe tube 542 with the proximal end 522 a of the body 522 ofthe needle assembly 520, the syringe tube 542 and the body 522 of theneedle assembly 520 form a fluid-tight seal with one another. The distalend 544 of the syringe tube 542 may include a valve configured to remainclosed until the body 522 of the needle assembly 520 is receivedtherein.

In use, the needle assembly 520 is deployed to capture a tissue specimenin the needle 524 of the needle assembly 520. With the tissue specimencaptured in the needle 524, the plunger 548 is moved distally to advancethe syringe tube 542 into engagement with the body 522 of the needleassembly 520. As mentioned above, coupling the syringe tube 542 with thebody 522 of the needle assembly 520 forms a fluid-tight seal between theopening 526 in the proximal end 522 a of the body 522 of the needleassembly 520 and the opening 546 defined in the distal end 544 of thesyringe tube 542. As the biopsy device 500 is withdrawn from the tissuesite, the liquid disposed in the syringe tube 542 applies a negativepressure on the tissue specimen to prevent the tissue specimen fromexiting the needle 524 during extraction. After extraction, the tissuespecimen may be discharged from the needle 524 by distally advancing theplunger 548 of the syringe 540.

With reference to FIG. 21, an external fluid station 600 may be providedwhich is configured to assist in extracting the tissue specimen from anyof the biopsy devices described herein. The fluid station 600 includes abase 602 and a plunger 604. The base 602 defines an elongated channel606 that contains a fluid therein. The plunger 604 defines alongitudinally-extending passageway 608 dimensioned for receipt of aneedle of one of the disclosed biopsy devices. Upon positioning a needlein the passageway 608, a needle tip of the needle extends distally outof the plunger 604 and into the fluid contained in the base 602. Toextract the tissue specimen from the needle, the plunger 604 is advanceddistally relative to the base 602 to force the liquid through the needletip. As the liquid is force up through the needle tip, the tissuespecimen travels proximally through the needle and out of the biopsydevice.

With reference to FIGS. 22-31, another embodiment of a biopsy device 700is illustrated. The biopsy device 700 generally includes a display 702,an ultrasonic probe 710, and a needle assembly 760. The display 702 isdisposed on a head 704 of the biopsy device 700 and is in electricalcommunication with the ultrasonic probe 710 such that any informationsensed by the ultrasonic probe (e.g., tissue structure) is displayed onthe display 702. The head 704 may include a processor in communicationwith the display 702 and the ultrasonic probe 710 for processing theinformation sensed by the ultrasonic probe 710.

With specific reference to FIGS. 22-26, the biopsy device 700 furtherincludes a tubular shaft 706 extending distally from the head 704. Inembodiments, the tubular shaft 706 may be monolithically formed with orintegrally connected to the head 704, The tubular shaft 706 has a needlehousing 708 fixed to a distal end portion thereof. The needle housing708 includes a pair of tabs or stops 709 a, 709 b extending laterallyoutward from opposite sides thereof.

The ultrasonic probe 710 includes a housing 712 pivotably coupled to thedistal end portion of the tubular shaft 706 and an end cap 714 securedto the housing 712. The end cap 714 has a block 716 that supports a pairof ultrasonic sensors 718 a, 718 b (FIG. 26). The block 716 may befabricated from silicone or any other suitable ultrasound-opaquematerial. The block 716 defines a central opening 720 therethroughdimensioned for slidable receipt of a needle 762 of the needle assembly760. The ultrasonic sensors 718 a, 718 b are in communication with theprocessor and/or the display 702 and are laterally spaced from oneanother to accommodate the needle 762 of the needle assembly 762therebetween. In this way, the needle 762 may be moved through theultrasonic probe 710 without inhibiting its function.

Disposed within the tubular shaft 706 is an axially movable inner sheath750. The inner sheath 750 is resiliently biased in a proximal directionby a biasing member 752 (e.g., an extension spring) that interconnectsthe inner sheath 750 and the head 704. The inner sheath 750 includes apair of tabs or stops 754 a, 754 b located at a distal end portionthereof that matingly engage with the stops 709 a, 709 b of the needlehousing 708 upon the inner sheath 750 moving from a proximal position(shown in FIG. 25) to a distal position (shown in FIG. 29). As such,when the inner sheath 750 is in the distal position, the inner sheath750 is prevented from being retracted by the biasing member 752 towardthe proximal position.

The inner sheath 750 defines a pair of longitudinally-extending channels756 a, 756 b in an outer surface thereof. The channels 756 a, 756 b ofthe inner sheath 750 permit longitudinal movement of respective arms 780a, 780 b of the needle assembly 760 therethrough. The inner sheath 750includes a flexible locking member 758 located at a proximal end of oneof the channels 756 a, 756 b. The locking member 758 of the inner sheath750 is configured to releasably capture one of the arms 780 a, 780 b ofthe needle assembly 760 upon the needle assembly 760 entering aretracted position. The locking member 758 is adjacent an end of anactuator or trigger 740 (FIG. 27) of the biopsy device 700. The actuator740 is pivotably coupled to the tubular shaft 706 and is configured toflex or bend the locking member 758 of the inner sheath 750 inwardly toselectively disengage the locking member 758 of the inner sheath 750from the arm 780 a of the needle assembly 760. As will be described indetail below, the inner sheath 750 functions to automatically retractthe needle assembly 760 back to the retracted state after the needleassembly 760 is deployed.

The needle assembly 760 of the biopsy device 700 generally includes aneedle subassembly 764 and the needle 762 extending distally from theneedle subassembly 764. The needle subassembly 764 includes a pair ofdistally-extending legs 766 a, 766 b each having a ramped distal end 768a, 768 b. The ramped distal ends 768 a, 768 b of the legs 766 a, 766 bare configured to engage with the stops 754 a, 754 b of the inner sheath750 upon the needle assembly 760 moving distally into the deployedposition. As will be described in greater detail below, as the rampeddistal ends 768 a, 768 b of the legs 766 a, 766 b engage the respectivestops 754 a, 754 b of the inner sheath 750, the stops 754 a, 754 b ofthe inner sheath 750 are forced radially outward and therefore out ofengagement with the stops 709 a, 709 b of the needle housing 708.

The needle subassembly 764 further includes a pair of arms 780 a 780 bextending radially outward of the inner sheath 750. The arms 780 a, 780b are coupled to a collar or slider 782 that is slidably attached to thetubular shaft 706 such that axial movement of the collar 782 along theelongated shaft 706 causes axial movement of the needle assembly 760.The collar 782 defines a pair of longitudinal tracks 784 a, 784 btherealong and a pair of circumferential notches 786 a, 786 b (FIG. 28)therein. The longitudinal tracks 784 a, 784 b and the circumferentialnotches 786 a, 786 b are each configured for selective receipt of thearms 780 a, 780 h of the needle subassembly 764. In one instance, whenthe arms 780 a, 780 h of the needle subassembly 764 are received in therespective tracks 784 a, 784 b of the collar 782, the needle subassembly764 is axially movable through the tracks 784 a, 784 b and relative tothe collar 782. In another instance, when the arms 780 a, 780 b of theneedle subassembly 764 are received within the respective notches 786 a,786 b (FIG. 28) defined in the collar 782 (due to a rotation of thecollar 782), axial movement of the collar 782 causes the needlesubassembly 764 to move with the collar 782.

The biopsy device 700 includes a pair of needle actuators 788, 790(e.g., springs) that extend between a proximal cap 759 of the innersheath 750 and a proximal end of the needle subassembly 764. In someembodiments, the biopsy device 700 may include more or less than twoneedle actuators. The needle actuators 788, 790 resiliently bias theneedle assembly 760 distally away from the proximal cap 759 of the innersheath 750 toward a deployed position.

An exemplary use of the biopsy device 700 will now be described withreference to FIGS. 23 and 28-31. The biopsy device 700 may be used toextract tissue samples from a lesion, for example, a tumor to be tested.With the needle 762 disposed within needle housing 708 in a positionproximal to opening 720 in the ultrasonic probe 710, as shown in FIG.23, the biopsy device 700 is positioned such that the block 716 of theultrasonic probe 710 is in abutting engagement with an outer surface oftissue breast tissue). The ultrasonic sensors 718 a, 718 b (FIG. 26) ofthe ultrasonic probe 710 are activated to emit an ultrasonic field in adistal direction through the block 716 and toward the lesion. Theultrasonic sensors 718 a, 718 b then receive the reflected sound wavesand the processor of the biopsy device 700 generates an image of theneedle tip of the needle 762 and the lesion on the display 702. Thebiopsy device 700 is moved relative to the target tissue until theneedle tip is shown on the display 702 as being aligned with the targettissue.

With reference to FIGS. 23 and 28, with the needle 762 in the properposition, the biopsy device 700 may be cocked in preparation for firingthe needle assembly 760. To cock or set the needle assembly 760, thecollar 782 is rotated relative to the arms 780 a, 780 b of the needlesubassembly 764 to position the arms 780 a, 780 h of the needle assembly764 in the notches 786 a, 786 b of the collar 782. With the arms 780 a,780 b of the needle subassembly 764 captured in the notches 786 a, 786 bof the collar 782, proximal movement of the collar 782 along the tubularshaft 706 results in a retraction of the needle assembly 760 toward theproximal cap 759 of the inner sheath 750. Upon the needle subassembly764 engaging the proximal cap 759 of the inner sheath 750, one of thearms 780 a, 780 b of the needle subassembly 764 is received in theflexible locking member 758 of the inner sheath 750 to lock together theneedle assembly 760 and the inner sheath 750, as shown in FIG. 28. Inaddition to locking the needle assembly 760 with the inner sheath 750,proximal retraction of the needle assembly 760 within the tubular shaft706 acts to compress the needle actuators 788, 790 between the needlesubassembly 764 and the proximal cap 759 of the inner sheath 750.

To further prepare the biopsy device 700 for firing, the collar 782 isadvanced distally along the elongated shaft 706, which, in turn, drivesdistal advancement of the needle assembly 760 due to the arms 780 a, 780b of the needle assembly 764 being captured in the notches 786 a, 786 bof the collar 782. As a result of arms 780 a of the needle assembly 764being in locking engagement with the locking member 758 of the innersheath 750, as the needle assembly 760 moves distally the inner sheath750 follows. As the inner sheath 750 moves toward a distal positionwithin the tubular shaft 706, the stops 754 a, 754 b of the inner sheath750 pass over and interlock with the stops 709 a, 709 b of the needlehousing 708, as shown in FIG. 29. Since the needle housing 708 is fixedrelative to the tubular shaft 706, the proximally-oriented force appliedto the inner sheath 750 by the biasing member 752 (FIG. 27) will notresult in proximal movement of the inner sheath 750 back toward theretracted position. As such, the collar 782, the needle assembly 760,and the inner sheath 750 are each prevented from moving proximally outof the position shown in FIG. 29. In this pre-fired position, the needle762 is held within the opening 720 defined in the block 716 of theultrasonic transducer 710 without protruding distally from theultrasonic probe 710.

With reference to FIGS. 29 and 30, prior to firing the actuator 740(FIG. 27), the collar 782 is rotated to displace the arms 780 a, 780 bof the needle subassembly 764 out of the notches 786 a, 786 b of thecollar 782 and into the longitudinal tracks 784 a, 784 b of the collar782. As can be appreciated by viewing, for example, FIG. 30, the collar782 is prevented from moving distally relative to and along theelongated shaft 706 by virtue of an abutting engagement with the housing712 of the ultrasonic probe 710. As such, the collar 782 acts as asafety by preventing distal movement of the needle assembly 760 relativethereto due to the arms 780 a, 780 b of the needle subassembly 764 beingcaptured within the notches 786 a, 786 b of the collar 782. Prior torotating the collar 782, incidental firing of the actuator 740 (FIG. 27)will not result in the firing of the needle assembly 760.

With the arms 780 a, 780 b of the needle subassembly 764 disposed withinthe tracks 784 a, 784 b of the collar 782, the needle assembly 760 isfree to move distally along and relative to the collar 782 but for thelocking engagement of the locking member 758 of the inner sheath 750with the arm 780 a of the needle subassembly 764. To deploy the needleassembly 760, the actuator 740 (FIG. 27) is pivoted into engagement withthe locking member 758 of the inner sheath 750, which, in turn, movesthe locking member 758 of the inner sheath 750 out of locking engagementwith the arm 780 a of the needle subassembly 764. With the arm 780 a ofthe needle subassembly 764 released from the locking member 758 of theinner sheath 750, the needle actuator 788 is free to push the needleassembly 760 distally relative to the inner sheath 750 to deploy theneedle 762 through and distally beyond the ultrasonic transducer 710 andinto tissue. The second needle actuator 790 either occludes the proximalend of the needle assembly to create a passive vacuum or pushes theouter sheath of the side-biting needle over the inner core.

As the needle assembly 760 completes its deployment, the ramped distalends 768 a, 768 b of the legs 766 a, 766 b of the needle subassembly 764concurrently depress the stops 709 a, 709 b of the needle housing 708thereby releasing the stops 754 a, 754 b of the inner sheath 750 fromthe stops 709 a, 709 b of the needle housing 708. Upon release of theinner sheath 750 from the needle housing 708, the biasing member 752(FIG. 27) in the head 704 drives the inner sheath 750 proximally towardthe retracted position (as shown in FIG. 31). Proximal movement of theinner sheath 750 causes the needle assembly 760 to be retracted due tothe engagement of the stops 754 a, 754 b of the inner sheath 750 and theramped distal ends 768 a, 768 b of the needle subassembly 764. In thisway, the needle 762 is immediately and automatically retracted back intothe housing 712 of the ultrasonic probe 710 upon finishing itsdeployment. With tissue captured in the needle 762, a proximal end ofthe needle subassembly 764 is occluded by the movement driven byactuator 790, thereby creating a passive vacuum in the needlesubassembly 764 to hold the tissue sample in the lumen of the needle762. In embodiments, the tissue may be captured by forming an activevacuum from a plunger (not shown) activated as the needle 762 isretracted back into the housing 712. Needle actuator 752 retracts theinner sheath 750 and all components within it until the needle iscompletely enclosed behind the distal end of the ultrasound probe.

To remove the needle 762 from the needle subassembly 764, the ultrasonicprobe 710 may be pivoted relative to the tubular shaft 706 to allow aclinician to gain access to the needle housing 708. The needle housing708 may then be detached from the tubular shaft 706 by, e.g., unscrewingit from the distal end portion of the tubular shaft 706. With the needlehousing 708 detached from the tubular shaft 706, the needle 762 isaccessible by a clinician and may be removed from the biopsy device 700.With the needle 762 removed, the tissue sample may be extracted from theneedle 762 and a new, sterile needle may be loaded into the biopsy,device 700 in preparation of reuse of the biopsy device 700.

While several embodiments of the disclosure have been shown in thedrawings, it is not intended that the disclosure be limited thereto, asit is intended that the disclosure be as broad in scope as the art willallow and that the specification be read likewise. Therefore, the abovedescription should not be construed as limiting, but merely asexemplifications of particular embodiments. Those skilled in the artwill envision other modifications within the scope and spirit of theclaims appended hereto.

What is claimed is:
 1. A method of performing a biopsy, comprising:positioning a biopsy device in proximity to target tissue; generating animage of the target tissue on a display of the biopsy device using anultrasonic probe of the biopsy device; aligning a needle of a needleassembly that is disposed within the ultrasonic probe with the targettissue using the image of the target tissue generated on the display;and deploying the needle of the needle assembly from the ultrasoundprobe into the target tissue, thereby capturing a tissue sample from thetarget tissue in the needle.
 2. The method of claim 1, wherein aligningthe needle with the target tissue includes moving the biopsy devicerelative to the target tissue into a position in which a projectedneedle pathway animated on the display is in line with the image of thetarget tissue on the display.
 3. The method of claim 2, whereindeploying the needle into the target tissue includes guiding the needleinto the target tissue along the projected needle pathway.
 4. The methodof claim 1, further comprising automatically capturing an image of theneedle of the needle assembly with the tissue sample disposed therein.5. The method of claim 1, further comprising abutting a force sensor ofthe biopsy device with a tissue surface to determine a resistance of thetarget tissue prior to deploying the needle into the target tissue. 6.The method of claim 1, further comprising applying a negative pressureto the needle assembly to draw the tissue sample into a containmentchamber defined in the needle assembly.
 7. The method of claim 6,wherein the negative pressure is applied using at least one ofhydraulics or a vacuum.
 8. The method of claim 1, further comprisingautomatically retracting the needle into the ultrasound probe afterdeploying the needle of the needle assembly from the ultrasound probeinto the target tissue.
 9. The method of claim 8, wherein duringdeployment of the needle, a leg of the needle assembly advances todisengage an inner sheath of the biopsy device from a housing of thebiopsy device and axially fixes the inner sheath with the needleassembly such that the inner sheath and the needle assemblyautomatically retract together as one unit.
 10. The method of claim 9,wherein the leg of the needle assembly disengaging the inner sheath fromthe housing includes releasing a tab of the inner sheath from a stop ofthe housing.
 11. The method of claim 10, wherein axially fixing theinner sheath with the needle assembly includes matingly engaging the legof the needle assembly with the tab of the inner sheath.
 12. The methodof claim 9, wherein the needle is automatically retracted by a biasingmember that exerts a proximally-oriented force on the inner sheath. 13.The method of claim 1, further comprising rotating a collar of thebiopsy device from a first orientation to a second orientation prior todeploying the needle, the collar and the needle assembly are axiallymovable with one another when the collar is in the first orientation,and the needle assembly is axially movable relative to the collar whenthe collar is in the second orientation.
 14. The method according toclaim 1, further comprising advancing the needle assembly from aretracted position to an intermediate, pre-fired position, wherein theneedle is deployed from the intermediate, pre-fired position.
 15. Amethod of performing a biopsy, comprising: positioning a biopsy devicein proximity to target tissue; generating an image of the target tissueon a display using an ultrasonic probe of the biopsy device; aligning aneedle of a needle assembly of the biopsy device with the target tissueusing the image of the target tissue generated on the display; advancingthe needle of the needle assembly through the ultrasound probe into thetarget tissue, thereby capturing a tissue sample from the target tissuein the needle; and automatically retracting the needle into the biopsydevice upon capturing the tissue sample from the target tissue.
 16. Themethod of claim 15, wherein during the advancing of the needle, an innersheath of the biopsy device is transitioned from a first state, in whichthe inner sheath is axially fixed within the biopsy device and theneedle is axially movable relative to the inner sheath, to a secondstate, in which the inner sheath is axially movable within the biopsydevice and axially fixed with the needle.
 17. The method of claim 16,wherein the needle is automatically retracted by a biasing member thatexerts a proximally-oriented force on the inner sheath, the needleautomatically retracting after the inner sheath transitions to thesecond state.
 18. The method of claim 17, wherein during advancement ofthe needle, a leg of the needle assembly advances to simultaneouslyrelease a tab of the inner sheath from a stop of the biopsy device andmatingly engage the tab of the inner sheath such that the inner sheathand the needle assembly automatically retract together as one unit. 19.The method of claim 15, further comprising rotating a collar of thebiopsy device from a first orientation to a second orientation prior toadvancing the needle, the collar and the needle assembly are axiallymovable with one another when the collar is in the first orientation,and the needle assembly is axially movable relative to the collar whenthe collar is in the second orientation.
 20. The method according toclaim 19, further comprising advancing the needle assembly from aretracted position to an intermediate, pre-fired position while thecollar is in the first orientation, wherein the needle is deployed fromthe intermediate, pre-fired position after the collar is rotated to thesecond orientation.